A Single Dose of Psilocybin for Treatment-Resistant Depression

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According to the results of a phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD), the largest study of its kind, patients with TRD could see symptom relief after a single dose of psilocybin.¹

Investigators gathered 233 participants with TRD and gave them either 1 mg, 10 mg, or 25 mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Approximately 30% of participants with TRD in the randomized, controlled, double-blind phase 2b study were in remission at week 3 after a single 25 mg dose of COMP360 psilocybin therapy. The difference between the 25 mg group and 1 mg group was -6.6 on the MADRS depression scale at week 3 (p<0.001).

“Over 100 million people around the world suffer with [TRD], and haven’t found relief from existing therapies. With every new treatment, the chance of responding decreases significantly, and patients become even more hopeless. Yet in this study, a substantial number of patients in the 25mg group experienced improvement in their symptoms of depression, with the effects lasting for up to 3 months,” said Scott Aaronson, MD, Chief Science Officer of the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Health System, and a principal investigator on the trial.²

Participants who received a 25 mg dose also had double the sustained response at week 12 (20.3%), as compared with those who received 1 mg (10.1%). COMP360 psilocybin was generally well-tolerated; on the day of administration, common adverse events included headache, nausea, and dizziness.

“We saw positive results in a particularly difficult to treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognized as a new treatment option in the future,” said Guy Goodwin, MD, DPhil, Chief Medical Officer at COMPASS Pathways. “We look forward to starting our phase 3 program later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”

References

1. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med. 2022;387(18):1637-1648.

2. COMPASS Pathways announces publication of phase 2b study of COMP360 psilocybin therapy for treatment-resistant depression in The New England Journal of Medicine. News release. November 3, 2022. Accessed November 4, 2022. https://compasspathways.com/compass-pathways-announces-publication-of-phase-2b-study-of-comp360-psilocybin-therapy-for-treatment-resistant-depression-in-the-new-england-journal-of-medicine/